At the end of this trial, all original data without participants’ name and the random sequences will be sent to a statistician for data analysis. Statistical analysis will be performed using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA). Significance level will be set at α = 0.05. Quantitative variables expressed as means ± standard deviation or median with interquartile range, and categorical data will be recorded as numbers and percentages. Between-group differences of continuous variables will be tested for significance using Student t test when original data or data via transformation of variables is normally distributed or using Wilcoxon rank-sum test when data is not normally distributed. A chi-square test will be used for categorical data.

The primary end point, ulcer recurrence, will be analyzed according to the intention-to-treat principle, with event curves for the time to the first event on the basis of Kaplan–Meier analysis, and treatments will be compared by means of the log-rank test. A cox regression model will be used to calculate the hazard ratio for the primary end point. Among secondary end points, plantar pressures at baseline and at 3, 6, 9, and 12 months will be compared with repeated measures ANOVA. The changes blood flow parameters of lower extremity at baseline and at 12 months will be compared using Student t test when these means between groups are comparable at baseline or using analysis of covariance (ANCOVA) when these means are not equivalent at baseline. For cardiovascular events, the hazard ratio for the comparison of treatment group with control group and 95% confidence intervals will be estimated with the use of a proportional-hazards model.

The footwear adherence will be calculated for each group and then ulcer recurrence rates will be compared between the subgroups of patients with high adherence and low adherence by χ2 tests. We also plan to explore whether potentially important covariates such as age, sex, body mass index, physical activity, and diabetic duration could potentially confound the results.

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